Hydrocortisone Butyrate
Drug - Hydrocortisone Butyrate
The trade name of the product as shown on the labeling.
Dosage -
SOLUTION; TOPICAL
The product dosage form and route separated by a semi-colon.
Active Ingredient(s) -
Hydrocortisone Butyrate
Multiple ingredients are in alphabetical order.
Strength -
0.1%
The potency of the active ingredient(s), Hydrocortisone Butyrate. May repeat for multiple part products.
Applicant -
TARO PHARM INDS
The firm name holding legal responsibility for Hydrocortisone Butyrate. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
076364
The FDA assigned number to Hydrocortisone Butyrate. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Hydrocortisone Butyrate. Each strength is a separate product. May repeat for multiple part products. Format is nnn.
Therapeutic Equivalence (TE) Code -
AT
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.
Approval Date -
Jan 14, 2004
The date Hydrocortisone Butyrate was approved as stated in the FDA approval letter to the applicant. The format is Mmm dd, yyyy. Products approved prior to the January 1, 1982 contain the phrase: "Approved prior to Jan 1, 1982".
Reference Listed Drug (RLD) -
No
The pioneer or innovator of Hydrocortisone Butyrate. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.
Type -
RX
The group or category of approved drugs Hydrocortisone Butyrate is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Taro Pharmaceutical Industries Ltd
The full name of the firm holding legal responsibility for the new application of Hydrocortisone Butyrate.
Hydrocortisone Butyrate
|
